Abstract
Neonates have long been a vulnerable population to unstudied therapies, starting as early as the late nineteenth century with Mrs. Winslow’s Soothing Syrup, a purported remedy for teething that contained alcohol and morphine sulfate, causing numerous infant deaths (1). In 1959, Gray baby syndrome was first reported in infants receiving large doses of chloramphenicol as a broad spectrum antibacterial agent (2), and in 1983, Mulhall et al. (3) noted the altered pharmacokinetics (PK) of chloramphenicol in neonates and young infants resulting in elevated serum levels and some toxic effects.
Highlights
Neonates have long been a vulnerable population to unstudied therapies, starting as early as the late nineteenth century with Mrs Winslow’s Soothing Syrup, a purported remedy for teething that contained alcohol and morphine sulfate, causing numerous infant deaths [1]
In 1959, Gray baby syndrome was first reported in infants receiving large doses of chloramphenicol as a broad spectrum antibacterial agent [2], and in 1983, Mulhall et al [3] noted the altered pharmacokinetics (PK) of chloramphenicol in neonates and young infants resulting in elevated serum levels and some toxic effects
During the last 50 years, we have witnessed amazing progress in neonatal care resulting in increased survival and improved outcomes for 23–24 weeks preterm infants and decreased morbidity and mortality associated with many neonatal diseases including primary pulmonary hypertension of the newborn (PPHN) and hypoxic ischemic encephalopathy (HIE)
Summary
Neonates have long been a vulnerable population to unstudied therapies, starting as early as the late nineteenth century with Mrs Winslow’s Soothing Syrup, a purported remedy for teething that contained alcohol and morphine sulfate, causing numerous infant deaths [1]. A number of studies submitted in response to the pediatric legislative initiatives have included neonatal information for sedation, gastroesophageal reflux disease, drugs used in surgery (adjunct to general anesthesia, reversal of non-depolarizing neuromuscular agents), thrombosis with systemic to pulmonary artery shunts, head lice (safety information related to benzyl alcohol exposure), prevention of bronchopulmonary dysplasia (BPD), treatment of mild/moderate pain or fever, and HIV infection [8]. It is not clear whether the lack of efficacy is accurate or is related to study design issues including the study population, disease characteristics in the neonate, drug properties (dose, tissue effect, metabolism), or the inability of the endpoints to reflect clinically meaningful outcomes.
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